DNLI Denali Therapeutics Inc.

52.83
-0.2  -0%
Previous Close 53.03
Open 52.41
52 Week Low 33.68
52 Week High 93.94
Market Cap $6,426,244,845
Shares 121,640,069
Float 78,409,082
Enterprise Value $5,208,092,859
Volume 1,854,707
Av. Daily Volume 520,838
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Upcoming Catalysts

Drug Stage Catalyst Date
DNL343
Amyotrophic lateral sclerosis (ALS)
Phase 1
Phase 1
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DNL788 (SAR443820)
Healthy volunteers
Phase 1
Phase 1
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DNL310
Hunter syndrome MPS II
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
DNL758 (SAR443122)
Cutaneous lupus erythematosus
Phase 2
Phase 2
Phase 2 initiation announced June 28, 2021.
DNL151 / BIIB122
Parkinson’s disease
Phase 2/3
Phase 2/3
Phase 2/3 trial planned for late-2021.
DNL758 (SAR443122)
COVID-19
Phase 1b
Phase 1b
Development has been halted - noted February 25, 2021.

Latest News

  1. SOUTH SAN FRANCISCO, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced that dosing recently commenced in a Phase 1b study of DNL343, its brain-penetrant small molecule activator of EIF2B, in participants diagnosed with amyotrophic lateral sclerosis (ALS).

    ALS, often called Lou Gehrig's disease, refers to a group of progressive neurodegenerative diseases that affect nerve cells in the brain and spinal cord, leading to loss of voluntary muscle control and movement. At least 20,000 people in the United States are currently affected…

    SOUTH SAN FRANCISCO, Calif., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced that dosing recently commenced in a Phase 1b study of DNL343, its brain-penetrant small molecule activator of EIF2B, in participants diagnosed with amyotrophic lateral sclerosis (ALS).

    ALS, often called Lou Gehrig's disease, refers to a group of progressive neurodegenerative diseases that affect nerve cells in the brain and spinal cord, leading to loss of voluntary muscle control and movement. At least 20,000 people in the United States are currently affected and approximately 5,000 individuals are newly diagnosed with ALS each year.

    "Initiation of this Phase 1b study marks a significant milestone in the development of DNL343 for the potential treatment of people living with ALS," said Carole Ho, M.D., Denali's Chief Medical Officer. "Our preclinical and Phase 1 healthy volunteer data demonstrate activity of DNL343 on biomarkers believed to be highly relevant to ALS, and we look forward to sharing this data at an upcoming scientific conference. This Phase 1b study will help further characterize the safety and activity of DNL343 in participants with ALS for whom treatment options are a critical unmet medical need."

    Denali plans to present the DNL343 Phase 1 healthy volunteer data at the 2021 Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting on October 6, 2021.

    About the Phase 1b study of DNL343 in ALS

    The Phase 1b clinical trial (study number NCT05006352) is a multicenter, randomized, placebo-controlled, double-blind, 28-day study followed by an 18-month open-label extension, designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of DNL343 in participants with ALS. Further information on the Phase 1b study can be accessed on the ClinicalTrials.gov website or by clicking here.

    About DNL343 and targeting EIF2B as a potential treatment for ALS

    Modulation of EIF2B activity with DNL343 is a novel and targeted investigational approach with first-in-class potential for the treatment of ALS. EIF2B is an intracellular protein complex that regulates protein synthesis and is required for neuronal health and function. When neurons experience stress, as occurs in ALS, EIF2B activity is suppressed. This leads to impaired protein synthesis and results in the formation of "stress granules," which are thought to be a precursor of TDP-43 aggregation, a hallmark pathology in ALS. DNL343 is designed to activate EIF2B and thereby restore protein synthesis, disperse TDP-43 aggregates, and improve neuronal survival.

    About Denali Therapeutics

    Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding Denali's progress, business plans, business strategy, product candidates, planned preclinical studies and clinical trials and expected milestones; EIF2B activators as therapy for amyotrophic lateral sclerosis; plans, timelines and expectations related to DNL343, including its use as a potential treatment of people living with amyotrophic lateral sclerosis; and statements made by Denali's Chief Medical Officer. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: any and all risks to Denali's business and operations caused directly or indirectly by the evolving COVID-19 pandemic; risk of the occurrence of any event, change or other circumstance that could give rise to the termination of Denali's collaboration agreements; Denali's early stages of clinical drug development; Denali's and its partners' ability to complete the development and, if approved, commercialization of its product candidates; Denali's and its partners' ability to enroll patients in its ongoing and future clinical trials; Denali's reliance on third parties for the manufacture and supply of its product candidates for clinical trials; Denali's and it's partners' ability to conduct or complete clinical trials on expected timelines; the risk that preclinical profiles of Denali's product candidates may not translate in clinical trials; the potential for clinical trials or clinical trials of any other product candidates to differ from preclinical, preliminary or expected results; the uncertainty that product candidates will receive regulatory approval necessary to be commercialized; Denali's ability to continue to create a pipeline of product candidates or develop commercially successful products; Denali's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; implementation of Denali's strategic plans for its business, product candidates and blood-brain barrier platform technology; and other risks, including those described in Denali's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 4, 2021, Denali's Annual Report on Form 10-K filed with the SEC on February 26, 2021, and Denali's future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Denali as of the date hereof. Denali disclaims any obligation to update any forward-looking statements, except as required by law.

    Investor Relations Contact:Media Contacts:
    Laura Hansen, Ph.D.

    Vice President, Investor Relations

    (650) 452-2747

    hansen@dnli.com
    Lizzie Hyland

    (646) 495-2706

    lizzie.hyland@fgh.com

    or

    Morgan Warners

    (202) 295-0124

    morgan.warners@fgh.com





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  2. SOUTH SAN FRANCISCO, Calif., Aug. 26, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced publication of preclinical proof of concept for using its Protein Transport Vehicle (PTV) to enhance brain uptake of peripherally administered progranulin (PTV:PGRN). This approach may have utility in treating certain types of frontotemporal dementia (FTD), especially FTD-GRN caused by progranulin deficiency.

    Published online Thursday, August 26th, ahead of print in the September 2nd issue of Cell, the preclinical research showed that progranulin replacement therapy…

    SOUTH SAN FRANCISCO, Calif., Aug. 26, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced publication of preclinical proof of concept for using its Protein Transport Vehicle (PTV) to enhance brain uptake of peripherally administered progranulin (PTV:PGRN). This approach may have utility in treating certain types of frontotemporal dementia (FTD), especially FTD-GRN caused by progranulin deficiency.

    Published online Thursday, August 26th, ahead of print in the September 2nd issue of Cell, the preclinical research showed that progranulin replacement therapy with Denali's PTV:PGRN rescued both neurodegeneration and microglial dysfunction in progranulin-deficient mice. The research also provides new insight into the molecular and cellular mechanisms that may contribute to FTD, identifying novel roles of progranulin in lysosomal function and lipid metabolism, as well as lysosome biomarkers with potential clinical utility.

    "This preclinical research demonstrates that our Protein Transport Vehicle can enhance the uptake of peripherally administered progranulin by multiple cell types in the brain, including neurons and microglia," said Denali's Chief Scientific Officer Joseph Lewcock, Ph.D. "In addition, the improved mechanistic understanding of progranulin's role in lysosomal function indicates that our therapeutic strategy with PTV:PGRN may be the most direct and effective way to increase progranulin levels in lysosomes for the potential treatment of people with FTD-GRN."

    PTV:PGRN is engineered to bind transferrin receptor molecules, which are present in large amounts on endothelial cells of the BBB and normally function to transport iron into the brain. This approach enables PTV:PGRN to be actively transported into the brain, potentially overcoming a long-standing challenge to the field of delivering protein therapeutics across the BBB.

    New insights on the role of progranulin and effects of PTV:PGRN in preclinical models of FTD

    Mutations in the GRN gene, which encodes the progranulin protein, generally result in reduced protein levels of progranulin and are amongst the most common genetic causes of FTD. The studies published in Cell used two common models of FTD-GRN, genetically engineered progranulin-deficient mice as well as iPSC-derived human microglial cells, to investigate the role of progranulin and effects of PTV:PGRN treatment on disease pathology.

    The preclinical research showed that lysosomes – which function as the "digestive system" of cells – are the primary cellular organelles impacted by progranulin deficiency. A new finding revealed in the preclinical studies was that progranulin regulates lysosomal function through binding to and stabilizing a lysosome-specific lipid, bis(monoacylglycero)phosphate (BMP), which is critical for normal lysosomal function.

    In the progranulin-deficient mice, BMP lipid levels were profoundly decreased, which resulted in reduced activity of the lipid-metabolizing enzyme glucocerebrosidase (GCase) and accumulation of the GCase substrate glucosylsphingosine (GlcSph); GCase is known to be involved in Gaucher disease and GBA-linked Parkinson's disease. A mild decrease in BMP and an increase in GlcSph was also found in biofluid samples from patients with FTD, with or without GRN mutations.

    Treatment of progranulin-deficient mice or human cells with PTV:PGRN was sufficient to rescue a range of lysosomal defects, including BMP deficiency, GlcSph accumulation, lysosomal vacuolization and lysosomal membrane damage. In addition, PTV:PGRN corrected lipofuscinosis, microgliosis and astrogliosis, which are common disease-relevant brain pathologies in progranulin-deficient mice that are also present in patients with FTD-GRN.

    "Collectively, these new insights from our preclinical research suggest that FTD-GRN may be an atypical lysosomal storage disorder, and that lysosomal function can be restored by PTV:PGRN," said Dr. Lewcock. "Our work also identified candidate clinical biomarkers indicative of lysosomal dysfunction, such as BMP and GlcSph, which may help to evaluate the future therapeutic efficacy of PTV:PGRN and other therapeutics in people with FTD-GRN."

    "Publication of this research in Cell marks a significant milestone in the development of therapeutics enabled by our Transport Vehicle technology," said Denali's Chief Executive Officer Ryan Watts, Ph.D. "We are making great progress towards our goal of initiating clinical testing of our lead PTV:PGRN molecule (DNL593) and believe that our unique brain-penetrant progranulin replacement approach has the potential to make a difference for individuals and their families affected by FTD-GRN."

    About Denali's TV Platform

    The BBB is essential in maintaining the brain's microenvironment and protecting it from harmful substances and pathogens circulating in the bloodstream. Historically, the BBB has posed significant challenges to drug development for CNS diseases by preventing most drugs from reaching the brain in therapeutically relevant concentrations. Denali's Transport Vehicle (TV) platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes, proteins, and oligonucleotides across the BBB after intravenous administration. The TV technology is based on engineered Fc fragments that bind to specific natural transport receptors, such as transferrin receptor, which are expressed at the BBB and deliver TV and its therapeutic cargo to the brain through receptor-mediated transcytosis. In animal models, antibodies and enzymes engineered to the TV technology demonstrate more than 10- to 30-fold greater brain exposure than similar antibodies and enzymes without this technology. Improved exposure and broad distribution in the brain may increase therapeutic efficacy by enabling widespread achievement of therapeutically relevant concentrations of product candidates.

    About Denali Therapeutics

    Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding Denali's plans, timelines and expectations related to PTV:PGRN, plans regarding planned future clinical studies of PTV:PGRN (DNL593), expectations regarding Denali's TV technology platform, the therapeutic potential of PTV:PGRN (DNL593) and Denali's TV platform, and statements made by Denali's Chief Scientific Officer and Chief Executive Officer. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: Denali's early stages of clinical drug development; Denali's and its partners' ability to complete the development and, if approved, commercialization of PTV:PGRN (DNL593); Denali's and its partners' ability to enroll patients in its ongoing and future clinical trials; Denali's reliance on third parties for the manufacture and supply of its product candidates for clinical trials; the potential for clinical trial results of PTV:PGRN (DNL593) to differ from preclinical or expected results, the risk that results from early preclinical biomarker studies will not translate to clinical benefit in clinical studies; and that PTV:PGRN (DNL593) may not receive regulatory approval as a treatment of FTD-GRN necessary to be commercialized. In light of these risks, uncertainties and assumptions, the forward-looking statements in this press release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Information regarding additional risks and uncertainties may be found in Denali's Annual and Quarterly Reports on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 26, 2021, and August 4, 2021, respectively, and Denali's future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali's expectations, except as required by law.

    Investor Relations Contact:

    Laura Hansen, Ph.D.

    Vice President, Investor Relations

    (650) 452-2747

    hansen@dnli.com

    Media Contacts:

    Lizzie Hyland

    (646) 495-2706

    Lizzie.Hyland@FGH.com

    or

    Morgan Warners

    (202) 295-0124

    Morgan.Warners@FGH.com



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  3. SOUTH SAN FRANCISCO, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today reported financial results for the second quarter ended June 30, 2021, and provided business highlights.

    "We recently announced positive interim data from a Phase 1/2 study of DNL310 in Hunter syndrome, our lead Transport Vehicle (TV)-enabled program, showing rapid normalization of key disease-specific biomarkers in cerebrospinal fluid. This was observed even at low dose regimens, which is consistent with robust and efficient crossing of the blood-brain barrier by DNL310…

    SOUTH SAN FRANCISCO, Calif., Aug. 04, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today reported financial results for the second quarter ended June 30, 2021, and provided business highlights.

    "We recently announced positive interim data from a Phase 1/2 study of DNL310 in Hunter syndrome, our lead Transport Vehicle (TV)-enabled program, showing rapid normalization of key disease-specific biomarkers in cerebrospinal fluid. This was observed even at low dose regimens, which is consistent with robust and efficient crossing of the blood-brain barrier by DNL310," said Ryan Watts, Ph.D., Denali's Chief Executive Officer. "We are also encouraged by early indications that exploratory clinical measures improved in the first cohort of five patients. In parallel with expanding the ongoing Phase 1/2 study, we are now focused on finalizing the design for and commencing a pivotal Phase 2/3 study in the first half of 2022. Furthermore, we are making significant progress in advancing additional TV-enabled programs towards clinical development as well as our broader therapeutic portfolio. We are on track to initiate late-stage clinical development with our LRRK2 inhibitor DNL151 (BIIB122) for Parkinson's disease in collaboration with Biogen by year end and to initiate a Phase 1b study with our EIF2B agonist DNL343 for amyotrophic lateral sclerosis (ALS) in the second half of this year."

    Recent Business Highlights

    Reported positive interim data from the Phase 1/2 study of ETV:IDS (DNL310) in patients with Hunter syndrome (MPS II): In July 2021, Denali announced longer-term safety data and 6-month biomarker data on DNL310 from Cohort A in a Phase 1/2 study in patients with Hunter syndrome. The data demonstrated durability of effect with CNS impact, improved peripheral activity after switching from standard of care, and a safety profile consistent with standard of care enzyme replacement therapy. Furthermore, initial indications of improved clinical symptoms and function, assessed as exploratory endpoints, were reported by investigators and parents in all five patients enrolled in Cohort A. Denali also shared data from Cohort B, which is designed to inform dose selection; exploratory biomarker data demonstrated activity of DNL310 across all dose regimens. Based on these data, Denali plans to begin enrolling Cohort C in the Phase 1/2 study to further investigate clinical endpoints and initiate a pivotal Phase 2/3 study of DNL310 in the first half of 2022.

    Phase 2 study of DNL758 (SAR443122) for cutaneous lupus erythematosus (CLE) initiated by Sanofi: In June 2021, Denali announced that its partner Sanofi commenced dosing in a Phase 2 study of DNL758, a peripherally-restricted small molecule inhibitor of RIPK1, in patients with CLE. Denali and Sanofi entered into a broad collaboration agreement in October 2018 for the global development and commercialization of RIPK1 inhibitors. This includes peripherally restricted molecules such as DNL758 and CNS-penetrant molecules such as DNL788 (SAR443820), which is being evaluated in a Phase 1 study in healthy volunteers with potential development for neurological indications such as amyotrophic lateral sclerosis, multiple sclerosis and Alzheimer's disease. Under the collaboration agreement, Denali received a milestone payment of $15 million from Sanofi in July 2021 related to the initiation of the Phase 2 study with DNL758. Sanofi is responsible for the development and commercialization and covers all costs of DNL758. Denali is entitled to receive development, regulatory and sales milestone payments and royalties on product sales.

    Met safety and biomarker goals in DNL151 (BIIB122) Phase 1/1b studies: In May 2021, Denali presented results from two studies of its small molecule LRRK2 inhibitor, DNL151 (BIIB122), in a Phase 1 study in healthy volunteers and a Phase 1b study in patients with Parkinson's disease, at the International Association of Parkinsonism and Related Disorders Virtual Congress. DNL151 (BIIB122) was generally well tolerated, and target engagement and pathway engagement biomarker goals were met. Denali and Biogen plan to initiate late-stage clinical development of DNL151 (BIIB122) in Parkinson's disease by year-end 2021.

    Summary Table of Upcoming 2021 Expected Key Milestones

    TimingInvestigational Drug CandidateTherapeutic AreaExpected Milestone
    2H 2021EIF2B activator (DNL343)ALS, FTDInitiate Phase 1b study in ALS patients
    2H 2021RIPK1 inhibitor (DNL788/SAR443820)ALS, Alzheimer's disease, MSPhase 1 data in healthy volunteers (Sanofi)
    Late 2021LRRK2 inhibitor (DNL151/BIIB122)Parkinson's diseaseInitiate late-stage clinical development in Parkinson's patients
    Late 2021PTV:PGRN (DNL593)FTDFile IND application or CTA
    Late 2021/Early 2022ATV:TREM2 (DNL919)Alzheimer's diseaseFile IND application or CTA

    Participation in Upcoming Investor Conferences

    Members of Denali's management will participate in the following upcoming investor conferences:

    • BTIG Virtual Biotechnology Conference 2021, August 9-10



    • 2021 Wedbush PacGrow Healthcare Conference, August 10-11



    • H.C. Wainwright 23rd Annual Global Investment Conference, September 13-15



    • Morgan Stanley 19th Annual Global Healthcare Conference, September 9-10 & 13-15



    • 2021 Cantor Virtual Global Healthcare Conference, September 27-30

    Second Quarter 2021 Financial Results

    For the three months ended June 30, 2021, Denali reported a net loss of $60.7 million compared with a net loss of $58.8 million for the three months ended June 30, 2020.

    Collaboration revenue was $22.9 million for the three months ended June 30, 2021, compared to $5.8 million for the three months ended June 30, 2020. The increase of $17.1 million in collaboration revenue was primarily due to the achievement of a $15.0 million milestone in June 2021 under our collaboration with Sanofi related to the initiation of the Phase 2 study of DNL758, as well as an increase in revenue of $2.4 million from our collaboration with Takeda and Biogen.

    Total research and development expenses were $65.7 million for the three months ended June 30, 2021, compared to $53.2 million for the three months ended June 30, 2020. The increase of approximately $12.5 million was primarily attributable to an increase in personnel-related expenses, including stock-based compensation, driven primarily by higher headcount and additional equity award grants at a higher market price. Additionally, there were increases in external expenses related to progression of Denali's portfolio, including costs related to the progress of the EIF2B and ETV:IDS programs in the clinic in 2021 and the development of the TV platform reflecting the increased investment in Denali's pipeline. These increases were partially offset by a decrease in external expenses related to the LRRK2 program primarily due to completion of the Phase 1 and 1b studies, as well as cost sharing reimbursements under our collaboration with Biogen.

    General and administrative expenses were $19.0 million for the three months ended June 30, 2021, compared to $14.0 million for the three months ended June 30, 2020. The increase of approximately $5.0 million was primarily attributable to an increase in personnel-related expenses, including stock-based compensation, driven primarily by higher headcount and additional equity award grants at a higher market price. Additionally, there were increases in and other general costs such as insurance, tax, IT and facilities related expenses. These increases were partially offset by a decrease in legal and other professional services expenses.

    Cash, cash equivalents, and marketable securities were approximately $1.4 billion as of June 30, 2021.

    About Denali Therapeutics

    Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding Denali's progress, business plans, business strategy, product candidates, planned preclinical studies and clinical trials and expected milestones; plans to conduct clinical development activities across various programs; plans, timelines and expectations related to DNL310 and Denali's TV technology, including our ability to advance two additional TV-enabled programs into the clinic for FTD and Alzheimer's disease; plans, timelines and expectations related to DNL151 of both Denali and Biogen, including with respect to initiation of late-stage clinical development; plans, timelines and expectations related to DNL343, including with respect to the initiation of future clinical trials; plans, timelines and expectations related to DNL788 and DNL758 of both Denali and Sanofi, including with respect to the availability of data and the initiation of future clinical trials and the payment of future milestone payments and royalties on product sales; Denali's expectations regarding DNL593 and DNL919 and plans and expectations regarding planned regulatory filings; Denali's priorities, regulatory approvals, timing and likelihood of success and expectations regarding collaborations; and statements made by Denali's Chief Executive Officer. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: any and all risks to Denali's business and operations caused directly or indirectly by the evolving COVID-19 pandemic; risk of the occurrence of any event, change or other circumstance that could give rise to the termination of Denali's agreements with Sanofi, Takeda, Biogen or any of Denali's other collaboration agreements; Denali's early stages of clinical drug development; Denali's and its partners' ability to complete the development and, if approved, commercialization of its product candidates; Denali's and its partners' ability to enroll patients in its ongoing and future clinical trials; Denali's reliance on third parties for the manufacture and supply of its product candidates for clinical trials; Denali's dependence on successful development of its blood-brain barrier platform technology and its current programs and product candidates; Denali's and its partners' ability to conduct or complete clinical trials on expected timelines; the risk that preclinical profiles of Denali's product candidates may not translate in clinical trials; the potential for clinical trials to differ from preclinical, early clinical, preliminary or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; the uncertainty that product candidates will receive regulatory approval necessary to be commercialized; Denali's ability to continue to create a pipeline of product candidates or develop commercially successful products; Denali's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; implementation of Denali's strategic plans for its business, product candidates and blood-brain barrier platform technology; and other risks, including those described in Denali's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2021 and Denali's future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Denali as of the date hereof. Denali disclaims any obligation to update any forward-looking statements, except as required by law.

    Denali Therapeutics Inc.
    Condensed Consolidated Statements of Operations
    (Unaudited)
    (In thousands, except share and per share amounts)
        
     Three Months Ended June 30, Six Months Ended June 30,
     2021 2020 2021 2020
    Collaboration revenue:       
    Collaboration revenue from customers(1)$22,936   $5,811   $30,858   $9,363  
    Other collaboration revenue3   36   4   88  
    Total collaboration revenue22,939   5,847   30,862   9,451  
    Operating expenses:       
    Research and development(2)65,711   53,152   125,918   104,168  
    General and administrative19,045   13,972   37,981   26,527  
    Total operating expenses84,756   67,124   163,899   130,695  
    Loss from operations(61,817)  (61,277)  (133,037)  (121,244) 
    Interest and other income, net1,126   2,598   2,305   5,667  
    Loss before income taxes(60,691)  (58,679)  (130,732)  (115,577) 
    Income tax benefit (expense)   (79)     56  
    Net loss$(60,691)  $(58,758)  $(130,732)  $(115,521) 
    Net loss per share, basic and diluted$(0.50)  $(0.56)  $(1.08)  $(1.11) 
    Weighted average number of shares outstanding, basic and diluted 121,291,435    105,717,912    121,089,174    104,068,815  

    ______________________________________

    (1) Includes related party collaboration revenue from customer of $0.8 million and $1.7 million for the three and six months ended June 30, 2021, respectively.

    (2) Includes an offset to expense from related party cost reimbursement of $1.6 million and $4.1 million for the three and six months ended June 30, 2021, respectively.  

    Denali Therapeutics Inc.
    Condensed Consolidated Balance Sheets
    (Unaudited)
    (In thousands)
     
     June 30, 2021 December 31, 2020
    Assets   
    Current assets:   
    Cash and cash equivalents$485,680  $507,144 
    Short-term marketable securities823,251  962,553 
    Cost sharing reimbursements due from related party1,567  5,674 
    Accounts receivable, net15,218  8,593 
    Prepaid expenses and other current assets16,029  11,691 
    Total current assets1,341,745  1,495,655 
    Long-term marketable securities92,522  32,699 
    Property and equipment, net40,350  40,846 
    Operating lease right-of-use asset31,622  32,618 
    Other non-current assets3,576  2,462 
    Total assets$1,509,815  $1,604,280 
    Liabilities and stockholders' equity    
    Current liabilities:   
    Accounts payable$4,235  $1,071 
    Accrued compensation6,295  20,503 
    Accrued manufacturing costs13,052  7,140 
    Accrued clinical and other research & development costs11,434  11,775 
    Other accrued costs and current liabilities2,148  3,037 
    Operating lease liability, current5,055  4,690 
    Related party contract liability, current3,438  3,569 
    Contract liabilities, current5,755  19,914 
    Total current liabilities51,412  71,699 
    Related party contract liability, less current portion292,293  293,849 
    Contract liabilities, less current portion31,308  23,325 
    Operating lease liability, less current portion61,396  64,175 
    Other non-current liabilities701  701 
    Total liabilities437,110  453,749 
    Total stockholders' equity1,072,705  1,150,531 
    Total liabilities and stockholders' equity$1,509,815  $1,604,280 

    Investor Relations Contact:

    Laura Hansen, Ph.D.

    Vice President, Investor Relations

    (650) 452-2747

    hansen@dnli.com

    Media Contacts:

    Lizzie Hyland

    (646) 495-2706

    lizzie.hyland@fgh.com

    or

    Morgan Warners

    (202) 295-0124

    morgan.warners@fgh.com

     



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    • Rapid reduction and sustained normalization of heparan sulfate in CSF demonstrated robust and durable CNS activity with intravenous administration, and enhanced peripheral activity with reductions in urine and serum heparan sulfate after switching from standard-of-care idursulfase

    • Global Impression of Change scales data suggested clinical improvement in overall MPS II symptoms, cognitive abilities, behavior, and physical abilities

    • Exploratory biomarker data demonstrated reductions in CSF lysosomal lipid biomarkers that are consistent with improved lysosomal function; and high variability in exploratory biomarker Nf-L was observed pre- and post-treatment

    • Safety profile with up to 43 weeks of dosing was consistent with standard of care enzyme replacement…
    • Rapid reduction and sustained normalization of heparan sulfate in CSF demonstrated robust and durable CNS activity with intravenous administration, and enhanced peripheral activity with reductions in urine and serum heparan sulfate after switching from standard-of-care idursulfase



    • Global Impression of Change scales data suggested clinical improvement in overall MPS II symptoms, cognitive abilities, behavior, and physical abilities



    • Exploratory biomarker data demonstrated reductions in CSF lysosomal lipid biomarkers that are consistent with improved lysosomal function; and high variability in exploratory biomarker Nf-L was observed pre- and post-treatment



    • Safety profile with up to 43 weeks of dosing was consistent with standard of care enzyme replacement therapy with infusion-related reactions being the most frequently observed adverse events



    • Based on these data, Denali is accelerating efforts to initiate a pivotal Phase 2/3 study in 1H 2022



    • Management will host a webinar for analysts and investors at 11:30 a.m. Eastern Time today

    SOUTH SAN FRANCISCO, Calif., July 25, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced additional positive interim data from a Phase 1/2 study evaluating ETV:IDS (DNL310), an investigational brain-penetrant enzyme replacement therapy intended to treat both central nervous system (CNS) and peripheral manifestations of Hunter syndrome (MPS II). The interim results being presented today at MPS 2021, the 16th International Symposium on MPS and Related Diseases, include safety data up to Weeks 43 and 25 from Cohorts A and B, respectively, 6-month biomarker data from Cohort A and up to 3-month biomarker data from Cohort B. Denali Management will host a webinar today for analysts and investors beginning at approximately 11:30 a.m. Eastern Time.

    "The longer-term safety data and 6-month biomarker data on DNL310 from Cohort A continue to demonstrate durability of effect with CNS impact, improved peripheral activity after switching from standard of care, and a safety profile consistent with standard of care enzyme replacement therapy," said Carole Ho, M.D., Denali's Chief Medical Officer. "We are also encouraged by initial indications of improved clinical symptoms and function reported by investigators and parents in all five patients enrolled in Cohort A. In addition, this is the first time we are sharing data from Cohort B, which is designed to inform dose selection, and exploratory biomarker data demonstrate activity of DNL310 across all dose regimens. Based on these data, we are accelerating our efforts to initiate a pivotal Phase 2/3 study of DNL310 in the first half of 2022 and to begin enrolling Cohort C in the Phase 1/2 study to further investigate clinical endpoints."

    This interim analysis of the Phase 1/2 study included data on five patients enrolled in Cohort A and 12 patients enrolled in Cohort B. All patients have neuronopathic MPS II disease except for one patient with non-neuronopathic MPS II disease in Cohort B. The median age of patients is 6 years in both cohorts, with the youngest patients aged 5 and 2 in Cohorts A and B, respectively. All patients received weekly intravenous doses of DNL310 after switching from idursulfase enzyme replacement therapy on Day 1 of the study. Data being presented include safety data up to Weeks 43 and 25 from Cohorts A and B, respectively; 6-month and up to 3-month biomarker data from Cohorts A and B, respectively; and exploratory clinical Global Impression of Change data from Cohort A up to Week 24.

    Results across Cohorts A and B showed that, following the switch from idursulfase to DNL310, the levels of heparan sulfate in cerebrospinal fluid (CSF) normalized in all patients analyzed (n=15), with rapid response observed in most patients (n=12) by Week 7, which is consistent with crossing of the BBB by DNL310 and activity in tissues of the CNS. Rapid normalization of CSF heparan sulfate at low dose regimens suggest that BBB crossing with Denali's Transport Vehicle (TV) was robust and efficient. Furthermore, the observed decline in urine and serum heparan sulfate was consistent with improved peripheral activity with DNL310.

    Exploratory clinical data suggest improved clinical symptoms and function for all five patients enrolled in Cohort A as reported by investigators and parents. Based on Global Impression of Change scales [Clinician Global Impression of Change (CGI-C) and Parent Global Impression of Change (PGI-C)], which are standardized assessment scales used to measure change, the data showed clinical improvement in overall MPS II symptoms, cognitive abilities, behavior, and physical abilities.

    Exploratory lysosomal lipid data showed reductions, which are consistent with improved lysosomal function: 10 of 15 patients across Cohorts A and B had normal GM3 ganglioside levels, including patients on low dose regimens and with shorter duration of treatment. In addition, reductions in levels of bis(monoacyl glycerol)-phosphate (BMP) and a potential reduction in levels of glucosylceramide (GlcCer) were observed in Cohort A at Week 24.

    High within patient variability in levels of neurofilament (Nf-L), an exploratory biomarker of neuronal structure, was observed pre- and post-treatment. Data from an ongoing observational natural history study conducted by Denali showed a marked increase in mean levels of serum Nf-L over a 4.5- to 6-month period in patients (n=3) who subsequently enrolled in Cohort A of the Phase 1/2 study. During the 6-month treatment period of the Phase 1/2 study, mean levels of serum and CSF Nf-L in Cohort A (n=5) showed a modest increase. Denali believes that the utility of Nf-L as a treatment response biomarker in MPS II will require further investigation.

    The safety profile of DNL310 remained consistent with standard of care enzyme replacement therapy. DNL310 was generally well tolerated with the most common treatment-emergent adverse events being infusion-related reactions (IRRs). IRRs occurred in 12 of 17 (71%) patients: the majority had mild (n=5) or moderate (n=6) IRRs, and 1 patient had severe IRRs. A total of 3 serious adverse events (SAEs) were reported: 1 previously reported SAE for a patient enrolled in Cohort A based on a mild IRR, and 2 SAEs in a patient enrolled in Cohort B based on severe IRRs. The SAEs resolved, and both patients are continuing in the study. All other treatment-emergent adverse events were mild or moderate.

    The study continues without modification following recommendation by an independent data monitoring committee on July 9, 2021.

    "DNL310 is our lead program enabled by our blood-brain barrier Transport Vehicle platform, and these data continue to validate the platform's potential as we advance additional TV-enabled programs toward the clinic," said Ryan Watts, Ph.D., Denali's Chief Executive Officer. "Our DNL310 program exemplifies application of Denali's core scientific principles to increase likelihood of success by targeting degenogenes, engineering therapeutics to cross the blood-brain barrier, and using biomarkers to inform development. We are encouraged by these interim data and we look forward to continued collaboration with the community to advance MPS II research and DNL310 as a potential treatment for affected individuals and their families."

    Families interested in learning more about Denali's efforts related to the discovery and development of therapeutics for the potential treatment of Hunter syndrome are invited to visit EngageHunter.com, the Denali Hunter syndrome community engagement website.

    Denali Webinar for Analysts and Investors

    Denali will host a webinar for analysts and investors to present the interim data from the Phase 1/2 study of DNL310. The webinar will begin at approximately 11:30 a.m. EDT / 8:30 a.m. PDT on Sunday, July 25, 2021, and will be available on Denali's corporate website on the Events page under the Investor section and can be accessed by following this link. An archived replay of the webinar will be available for at least 30 days following the event.

    About DNL310 and Hunter Syndrome (MPS II)

    Hunter syndrome (MPS II) is a rare neurodegenerative lysosomal storage disease caused by mutations in the gene that encodes for the enzyme iduronate-2-sulfatase (IDS). The resultant reduction or loss of IDS enzyme activity leads to accumulation of glycosaminoglycans, which causes lysosomal dysfunction and neurodegeneration as well as progressive damage to multiple organs including bone, cartilage, heart and lung. Current standard of care enzyme replacement treatment does not address neuronopathic manifestations of the disease as it does not sufficiently cross the blood-brain barrier (BBB). DNL310 is an investigational fusion protein composed of IDS fused to Denali's proprietary Enzyme Transport Vehicle (ETV), which is engineered to cross the BBB via receptor-mediated transcytosis into the brain. More information about the ongoing Phase 1/2 study of DNL310 in patients with Hunter syndrome can be found on ClinicalTrials.gov by following this link.

    About Denali's TV Platform

    The BBB is essential in maintaining the brain's microenvironment and protecting it from harmful substances and pathogens circulating in the bloodstream. Historically, the BBB has posed significant challenges to drug development for CNS diseases by preventing most drugs from reaching the brain in therapeutically relevant concentrations. Denali's TV platform is a proprietary technology designed to effectively deliver large therapeutic molecules such as antibodies, enzymes, proteins, and oligonucleotides across the BBB after intravenous administration. The TV technology is based on engineered Fc fragments that bind to specific natural transport receptors, such as transferrin receptor, which are expressed at the BBB and deliver TV and its therapeutic cargo to the brain through receptor-mediated transcytosis. In animal models, antibodies and enzymes engineered to the TV technology demonstrate more than 10- to 30-fold greater brain exposure than similar antibodies and enzymes without this technology. Improved exposure and broad distribution in the brain may increase therapeutic efficacy by enabling widespread achievement of therapeutically relevant concentrations of product candidates. ETV:IDS (DNL310) is Denali's lead TV-enabled program in Phase 1/2 development for the potential treatment of Hunter syndrome (MPS II).

    About the EngageHunter.com Website

    EngageHunter.com — the Denali Hunter syndrome (MPS II) community engagement website — is an online destination for emerging information on Denali's scientific advances in Hunter syndrome research and Denali's clinical trials. Visitors who register on the Engage Hunter website will receive updates on Denali's research and future Denali investigational studies.

    About Denali Therapeutics

    Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding Denali's plans, timelines and expectations related to DNL310, the DNL310 ongoing Phase 1/2 study and expectations regarding enrollment in Cohort C, plans to accelerate efforts to initiate the planned Phase 2/3 in the first half of 2022, plans regarding other planned future studies, expectations regarding Denali's TV technology platform, the therapeutic potential of DNL310 and Denali's TV platform, and statements made by Denali's Chief Medical Officer and Chief Executive Officer. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: Denali's early stages of clinical drug development; Denali's and its partners' ability to complete the development and, if approved, commercialization of DNL310; Denali's and its partners' ability to enroll patients in its ongoing and future clinical trials; Denali's reliance on third parties for the manufacture and supply of its product candidates for clinical trials; the potential for clinical trial results of DNL310 to differ from preclinical, preliminary or expected results, the risk that Denali will be able to continue dose escalation in the Phase 1/2 study, whether DNL310 will cause any serious adverse events, whether DNL310 will impact downstream biomarkers of neurodegeneration, the risk that results from early clinical biomarker studies will not translate to clinical benefit in late clinical studies; and that DNL310 may not receive regulatory approval as a treatment of Hunter syndrome necessary to be commercialized. In light of these risks, uncertainties and assumptions, the forward-looking statements in this press release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Information regarding additional risks and uncertainties may be found in Denali's Annual and Quarterly Reports filed on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 26, 2021, and May 5, 2021, respectively, and Denali's future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali's expectations, except as required by law.

    Investor Relations Contact:

    Laura Hansen, Ph.D.

    Vice President, Investor Relations

    (650) 452-2747

    hansen@dnli.com 

    Media Contacts:

    Lizzie Hyland

    (646) 495-2706

    Lizzie.Hyland@FGH.com 

    or

    Morgan Warners

    (202) 295-0124

    Morgan.Warners@FGH.com 



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  4. SOUTH SAN FRANCISCO, Calif., July 15, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced its participation at MPS 2021, the 16th Annual International Symposium of MPS and Related Diseases, a research conference dedicated to the exchange of knowledge on mucopolysaccharidoses and related syndromes, taking place virtually July 23-25, 2021. Details related to Denali's oral presentation at MPS 2021 and a webinar hosted by Denali management following the presentation are provided below.

    Oral Presentation at MPS 2021

    Session Title: Late Breaking News / Oral…

    SOUTH SAN FRANCISCO, Calif., July 15, 2021 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases, today announced its participation at MPS 2021, the 16th Annual International Symposium of MPS and Related Diseases, a research conference dedicated to the exchange of knowledge on mucopolysaccharidoses and related syndromes, taking place virtually July 23-25, 2021. Details related to Denali's oral presentation at MPS 2021 and a webinar hosted by Denali management following the presentation are provided below.

    Oral Presentation at MPS 2021

    Session Title: Late Breaking News / Oral Communications

    Presentation Title: Interim 24-Week Results of Cohort A in a Ph I/II Study of Intravenous DNL310 (brain-penetrant enzyme replacement therapy) in MPS II

    Date: Sunday, July 25th

    Session Start Time: 16:05 p.m. CEST / 10:05 a.m. EDT / 7:05 a.m. PDT

    Denali's presentation is the fifth presentation during the session and is slated to start at approximately 17:05 p.m. CEST / 11:05 a.m. EDT / 8:05 a.m. PDT.

    Denali Webinar for Analysts and Investors

    Following the presentation, Denali will host a webinar for analysts and investors to present the interim data from the Phase 1/2 study of DNL310. The webinar will begin at approximately 11:30 a.m. EDT / 8:30 a.m. PDT on Sunday, July 25, 2021, and will be available on Denali's corporate website on the Events page under the Investor section at https://www.denalitherapeutics.com/investors/events. An archived replay of the webinar will be available for at least 30 days following the event. Preregistration for the webinar can be accessed here.

    Families interested in learning more about Denali's efforts related to the discovery and development of therapeutics for the potential treatment of Hunter syndrome are invited to visit EngageHunter.com, the Denali Hunter syndrome community engagement website.

    About DNL310 and Hunter Syndrome (MPS II)

    Hunter syndrome (MPS II) is a rare neurodegenerative lysosomal storage disorder caused by a mutation in the gene that encodes for the enzyme iduronate-2-sulfatase (IDS). The resultant reduction or loss of IDS enzyme activity leads to accumulation of glycosaminoglycans, which causes lysosomal dysfunction and neurodegeneration as well as progressive damage to multiple organs including bone, cartilage, heart and lung. Current standard of care enzyme replacement treatment does not address neuronopathic manifestations of the disease as it does not sufficiently cross the blood-brain barrier (BBB). DNL310 is a fusion protein composed of IDS fused to Denali's proprietary Enzyme Transport Vehicle (ETV), which is engineered to cross the BBB via receptor-mediated transcytosis into the brain. Denali previously announced human biomarker proof-of-concept for its Transport Vehicle (TV) technology from Cohort A (n=5) of an ongoing Phase I/2 study of DNL310 in patients with Hunter syndrome. The study is currently enrolling Cohort B, and a Cohort C is planned to further explore clinical endpoints. More information about the ongoing Phase 1/2 study of DNL310 in patients with Hunter syndrome can be found on ClinicalTrials.gov by following this link.

    About the EngageHunter.com Website

    EngageHunter.com — the Denali Hunter syndrome (MPS II) community engagement website — is an online destination for emerging information on Denali's scientific advances in Hunter syndrome research and Denali's clinical trials. Visitors who register on the Engage Hunter website will receive updates on Denali's research and future Denali investigational studies.

    About Denali Therapeutics

    Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit www.denalitherapeutics.com.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding Denali's plans, timelines and expectations related to DNL310, the DNL310 ongoing Phase 1/2 study, and planned future studies, Denali's TV technology platform, and the therapeutic potential of DNL310 and Denali's TV platform. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: Denali's early stages of clinical drug development; Denali's and its partners' ability to complete the development and, if approved, commercialization of DNL310; Denali's and its partners' ability to enroll patients in its ongoing and future clinical trials; Denali's reliance on third parties for the manufacture and supply of its product candidates for clinical trials; the potential for clinical trial results of DNL310 to differ from preclinical, preliminary or expected results, the risk that Denali will be able to continue dose escalation in the Phase 1/2 study, whether DNL310 will cause any serious adverse events, whether DNL310 will impact downstream biomarkers of neurodegeneration, and that DNL310 may not receive regulatory approval as a treatment of Hunter syndrome necessary to be commercialized. In light of these risks, uncertainties and assumptions, the forward-looking statements in this press release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Information regarding additional risks and uncertainties may be found in Denali's Annual and Quarterly Reports filed on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 26, 2021, and May 5, 2021, respectively, and Denali's future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results or to make changes in Denali's expectations, except as required by law.

    Investor Relations Contact:

    Laura Hansen, Ph.D.

    Vice President, Investor Relations

    (650) 452-2747

    hansen@dnli.com

    Media Contacts:

    Lizzie Hyland

    (646) 495-2706

    Lizzie.Hyland@FGH.com

    or

    Morgan Warners

    (202) 295-0124

    Morgan.Warners@FGH.com



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